Melissa Kozak: Put Device Users First with Human Factors-Informed Procurement

Think about the last time you saw a demonstration of a new medical device. Were you guided through all the new and innovative features by an expert who was able to step in and assist with any questions or difficulties as you tried it for the first time?

Now think about the last time you found yourself interacting with a new-to-you medical device in a real-life, time-sensitive situation. Did you feel prepared and fully trained? Did you know exactly how to use it or did you have difficulty interacting with the medical device?

Sadly, there are many stories of medical devices that contribute to adverse events, which have resulted in harm to staff and patients. For example, there were five deaths and 68 injuries related to the incorrect programming of infusion pumps between 2007 and 2015 as reported in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. Most of these reported incidents involved cases where programming errors resulted in unintentional drug overdoses or underdoses being given to patients.

Adverse events involving medical devices aren’t just limited to the clinical setting either. Issues related to the service and repair of devices occur, too. For example, between 2007 and 2017, there were three deaths and 42 injuries related to device calibration errors reported in the MAUDE database.

Medical device design and the way that end users interact with medical devices should be an important consideration for hospitals today because devices that haven’t been designed, selected, and implemented with end users in mind can contribute to preventable adverse events.

One of the specialties that focus on understanding and preventing adverse events is human factors engineering. Human factors engineering is a discipline dedicated to identifying and addressing areas of mismatch between people, devices, technologies, and environments. When people use devices or work in environments that don’t support them, errors or near misses can occur. By designing, selecting, and implementing devices using human factors principles, we can consider the fit between system elements and understand how end users are likely to perform in the real world.

Recently, the FDA has helped to shine a spotlight on the importance of human factors engineering in the design and development of medical devices, with the release of published guidance and regulations to ensure vendors consider the fit between humans and devices during device design and development.

From a hospital perspective, this is good news, but it is just the tip of the iceberg. Because the needs of users in different hospitals and hospital settings can vary so greatly, it’s important for hospitals to consider the specific users and environments in which devices will be employed, in addition to hospital-level requirements, when procuring and implementing new medical devices. This careful consideration can be achieved through human factors-informed procurement.

Human factors-informed procurement is an approach to procurement that builds on traditional procurement processes and incorporates human factors methods and standards into the decision-making process. In this way, you can ensure the device supports end users in the intended context of use—in addition to selecting a product that meets technical specifications, clinical requirements, budgetary constraints, and comes from a reputable vendor that can provide training and support over time. This facilitates a good fit across the entire system, which includes your end users, devices, other interfacing technologies, environments of use, and the hospital or hospital system.

The first step in a human factors-informed procurement approach is to identify your stakeholders, including any and all end users. Next, identify the needs and wants of your stakeholders with respect to the new device. Include that information in your RFP, and evaluate the responses with that stakeholder feedback in mind. Once the field of potential devices has been narrowed, assess each potential device against technical specifications and budgetary constraints. Evaluate each potential device using human factors methods, such as heuristic analysis and usability testing.

Based on the results of all analyses, make a decision to move forward with the most appropriate device. Proceed with device and environment configuration—as well as training, education and support—informed by the results of heuristic and usability testing.

Taking a human factors-informed approach to procurement allows stakeholders, including end users, to have a say in this crucial process. This approach can also help with getting user buy-in, providing insight to the specific issues likely to occur in your context of use and allowing for implementation with the proper device and environment configuration, training and support plans in place. Further, adverse events due to device design issues are unlikely to occur, since most would have been identified during heuristic and usability testing. It’s at that stage that you have an opportunity to work with the vendor to solve any such issues prior to implementing the device in your institution.

For more information about human factors-informed procurement, see http://cedglobal.org/human-factors-for-health-technology-safety/

Melissa Kozak is a clinical engineer at the Techna Institute with University Health Network in Canada.

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2 Comments on “Melissa Kozak: Put Device Users First with Human Factors-Informed Procurement”

  1. J Scot Mackeil CBET Says:

    One of the most effective human factor engineering strategies is in the hands of the biomed who interacts with the salesman when a device is presented for a DEMO inspection. That biomed MUST require the salesman to provide him with an NFPA-99 2005 compliant factory service manual in PDF, the user manual in PDF, and to require the salesman to show the biomed how to set up and verify the function of the device as described in the factory service manual. If these conditions are not met, the biomed should tell the salesman the device fails inspection. Without factory service manuals , no device should pass a demo inspection and be allowed into a healthcare facility. This is the single most important human factor of all.

    Reply

  2. Salim Kai Says:

    Melissa, hello. Great blog!
    The use of human factors engineering in hospitals makes perfect sense, but it is underutilized in hospitals and by the manufacturers of medical devices. First, it is not fully adopted in the design phase by many companies and often is thought of as something to add on later after the device is on the market. Unfortunately, it is more like an afterthought when issues are reported in the field to FDA and the company is trying to improve the design, whether with labeling, software, hardware, etc., and not recall the product. Second, the use of human factors engineering is very limited postmarket by hospitals and HTM professionals for various reasons outside the scope of this blog.
    Also unfortunately, production pressures and competition among manufacturers to release devices to market without the proper safety testing and efficacy of data, where marketing and sales are in the driver’s seat, results in unintended consequences. Patients or ordinary people end up paying the price with injury or death.
    Another issue is with software complexity and connectivity of devices. There are many layers of menus and various interfaces which mislead users. We, HTM professionals, manage technology every day in the hospital and sometime find ourselves struggling to understand how to operate the user interface of a new piece of equipment. And we expect clinicians to have a full understanding of how to use the equipment? It’s not realistic.
    Adverse events related to inadequate service remain more ambiguous. Most events that end up in the MAUDE database are reported by manufacturer quality departments, physicians, risk management professionals, nurses, but not so much by HTM professionals who actually perform the maintenance, interact with the user to problem solve, and in the process discover where the weaknesses in the device design are. HTM professionals, whether techs or engineers provide a unique perspective about the usability and failure modes of the device that often go on not reported.
    For example, you may have a hospital bed that uses a hydraulic system to raise and lower the bed. The bed may leak hydraulic fluid on the floor and is repaired by the HTM tech and documented as a corrective maintenance in the CMMS. If this is related to a weak design, this same bed may be in use on an ortho patient who just completed a spine surgery and when the bed is abruptly lowered as a result of the loss of fluid it may impact the patient in a negative way and could result in an adverse event. Maintenance issues can be subtle and require the proper training to flag and to report. Nowadays, HTM departments are spread out pretty thin and do not have adequate resources to report. Also many hospital event reporting policies outline reporting to FDA be completed by risk management or the quality department. This may limit or prevent true maintenance issues resulting in close calls or in adverse events involving medical devices reaching the MAUDE database.
    I applaud what you mention incorporating HFE into the procurement phase. I believe there should be more common HFE tools for the average person that hospitals can use to make smarter purchasing decisions and keep patients safe.
    I am glad you wrote this blog about HFE as a discipline and to outline its significance. Well done!
    Salim

    Reply

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